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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003122
Receipt No. R000003391
Scientific Title Multi-center Study of Detection of Synchronous and Metachronous Contralateral Breast Cancer with Magnetic Resonance Imaging in Patients with Unilateral Breast Cancer
Date of disclosure of the study information 2010/02/03
Last modified on 2014/02/01

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Basic information
Public title Multi-center Study of Detection of Synchronous and Metachronous Contralateral Breast Cancer with Magnetic Resonance Imaging in Patients with Unilateral Breast Cancer
Acronym Multi-center Study of Detection of Synchronous and Metachronous Contralateral Breast Cancer with Magnetic Resonance Imaging in Patients with Unilateral Breast Cancer
Scientific Title Multi-center Study of Detection of Synchronous and Metachronous Contralateral Breast Cancer with Magnetic Resonance Imaging in Patients with Unilateral Breast Cancer
Scientific Title:Acronym Multi-center Study of Detection of Synchronous and Metachronous Contralateral Breast Cancer with Magnetic Resonance Imaging in Patients with Unilateral Breast Cancer
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the clinical usefulness of breast MRI for detection of contralateral breast cancer in the patient with breast cancer
Basic objectives2 Others
Basic objectives -Others We examined the significance of performing breast contrast-enhanced MR imaging, in addition to palpation and mammography, in screening for contralateral breast cancer in patients with unilateral breast cancer or a history of unilateral breast cancer. The sensitivity, specificity, and positive and negative predictive values for detection of contralateral breast cancer with contrast-enhanced MR imaging were determined in cases diagnosed as free from abnormal findings using palpation and mammography. These results were used to examine the significance of performing additional contrast-enhanced MR imaging. We also performed a questionnaire-based investigation of background factors including eating habits, fitness habits, smoking, favorite foods and beverages, family history, history of hormonal therapy, and academic background to examine possible risk factors for development of bilateral breast cancer, based on our data for the occurrence of synchronous and metachronous breast cancer.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Sensitivity, specificity, positive and negative predictive value of breast MRI to detect the contralateral breast cancer
Key secondary outcomes Safety of breast MRI, identification of lifestle risk factors about contralateral breast cancer

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 MRI evaluation of bilateral breast
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria histologically proven invasive breast cancer
ipsilateral breast cancer
no evidence of metastasis
Key exclusion criteria bilateral breast cancer
Has a contraindication to undergoing breast MRI
Patient is pregnant
Has a psychiatric or addictive disorder that would preclude obtaining informed consent or adherence to the protocol
Target sample size 660

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naruto Taira
Organization Okayama university hospital
Division name Breast and endocrine surgery
Zip code
Address 2-5-1 Shikata-cho, Kita ward, Okayama city
TEL 086-235-7265
Email ntaira@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naruto Taira
Organization Okayama university hospital
Division name Breast and endocrine surgery
Zip code
Address 2-5-1 Shikata-cho, Kita ward, Okayama city
TEL 086-235-7265
Homepage URL
Email ntaira@md.okayama-u.ac.jp

Sponsor
Institute Okayama university hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for Cancer Control from Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Osaka Medical Center for Cancer and Cardiovascular Diseases
Kawasaki medical school hospital
Saitama medical center
Kitasato university
Niigata cancer center hospital
Rinku general medical center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 03 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2014 Year 01 Month 01 Day
Date of closure to data entry
2014 Year 03 Month 01 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2014 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 01 Day
Last modified on
2014 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003391

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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